Course description: The purpose of this course is to learn how pharmaceutically active agents behave in the body and how they are delivered to the body. Topics to be covered include the study of how drugs are absorbed and distributed in organs and tissues; what chemical alterations a drug may undergo in the body; and how drugs are stored in the body and eliminated from it. The kinetics of drug absorption and tissue distribution will be mathematically modeled to better understand how drugs are processed in vivo. How the physical and chemical properties of the active agent relate to the absorption, distribution, metabolism, and elimination will also be probed. The time course of drug and metabolite levels in different fluids, tissues, and excreta of the body, and of the mathematical relationships required to interpret such data will be discussed.

In addition, the delivery of bioactive agents from pharmaceutical dosage forms will be evaluated. Pharmaceutical formulation will be studied including the engineering aspects of liquid, solid and aerosol dosage form design with emphasis on controlled drug delivery. The course will examine the transport phenomena involved in controlled release dosage form design and along with other novel delivery systems to administer drugs. Mathematical modeling of drug diffusion and analytical testing methods will be discussed. In addition, industrial processing and regulatory issues will be covered.

The purpose of this course is:

• To understand the physiology involved in absorption, distribution, metabolism and elimination of drugs
• To learn how pharmaceuticals are processed in vivo
• To characterize pharmacokinetic data and relate that to physical processes
• To model the release of bioactive agents
• To study the delivery of active agents from various dosage forms
• To appreciate the clinical, ethical and processing issues associated with the pharmaceutical sciences

Special features: This course includes extensive mathematical modeling of physiological processes using nonlinear differential equations, using numerical methods and Laplace transforms. There are also in class case studies where discussion is encouraged.

COURSE SCHEDULE | COURSE HOMEWORK

Integration into curriculum: BIOE 425 provides the students with many opportunities to apply what they have learned in their chemistry, transport phenomena (BIOE 420) numerical methods (BIOE 391) and physiology (BIOE 320) classes. BIOE 425 is an extension and continuation of BIOE 420 (Biosystems transport and reaction processes) with more in-depth focus on pharmacology. This course probes the physiochemical behavior of biologically active agents, provides extensive pharmokinetic modeling and emphasizes hepatic and renal physiology. This course allows the students to gain insight on how bioengineers can apply their knowledge to a specific industry.

Course prerequisites: Differential equations, Numerical methods and/or Transport phenomena

Textbook: Modern Pharmaceuticals 4 th edition , Gilbert S. Banker and Christopher Rhodes, editors, Marcel Dekker, NY 2002

Optional textbook: Clinical Pharmacokinetics, Concepts and Applications, 3 rd edition, Malcolm Rowland and Thomas N. Tozer, Lippincott Williams & Wilkins, Philadelphia, PA 1995

Pharmacokinetics, 2 nd edition, Mark Gibaldi, Donald Perrier, M. Dekker,Inc., 1982

http://www.boomer.org/c/p1/ course notes from UOK

Suggested reading

The Billion-Dollar Molecule , Berry Weath

Homework: There will be 6 homework assignments. These will be mostly problem solving assignments. The problems will require knowledge of analytical differential equations and numerical methods. They will be assigned typically on a Thursday and due the following Thursday. Students are not allowed to consult previous year's homework sets or exams when working on the problem sets. The tentative homework assignment dates are on the BIOE 425/625 lecture schedule. No late homework assignment will be accepted with out prior permission from the instructor.

Case studies: Approximately 4 in class problems will be assigned for individual and group discussions.

Exams: There will be a take-home final exam. The exams will have a 3-hour time limit. Students will be asked to sign an honor code statement for each exam. The final exam will be placed in a sealed envelope and may be picked up anytime during finals week and returned 48 hours later.

Research Project: The student will chose an FDA approved drug to characterize in a research paper (10 - 20 pages) and oral presentation (approx 20 minutes) The topic must be approved by the professor. The purpose of the project is to understand how, why, and when the drug is administered by delving into its pharmacokinetics and pharmaceutical properties. The paper should include a complete discussion of the properties of the active agent. Issues such as physico-chemical properties, biological activity, biological half life, targeted organs, metabolism, drug interactions, formulation, routes of delivery, pharmaceutical processing and side effects of the drugs should be covered in the paper. In addition, a 1 page design project should be proposed to address a drawback, weakness or negative aspect of the drug. For example, improvements in the delivery system, toxicity, drug interactions, targeting, physical properties, cost, manufacturing are potential areas that may be need improvement via an enhanced design.

Homework 30%
Case studies 10%
Project 30%
Final Exam 30%

Honor code

Students are encouraged ask questions and discuss problems with other students, the teaching assistant, or the instructor about homework assignments or the research project. Students are not allowed to copy answers from one another. Students may not consult previous years' homework sets or tests. The final exam will be open book and open notes, but Internet searching, or any communication about the exam is not allowed.

There will be a help session at a time to be determined.